Effect of 2 Years of Monthly Calcifediol Administration in Postmenopausal Women with Vitamin D Insufficiency.


Journal

Nutrients
ISSN: 2072-6643
Titre abrégé: Nutrients
Pays: Switzerland
ID NLM: 101521595

Informations de publication

Date de publication:
03 Jun 2024
Historique:
received: 02 04 2024
revised: 21 05 2024
accepted: 31 05 2024
medline: 19 6 2024
pubmed: 19 6 2024
entrez: 19 6 2024
Statut: epublish

Résumé

We assessed the long-term (24 months) efficacy and safety of monthly calcifediol (0.266 mg) in the correction and maintenance of total 25(OH)D levels in postmenopausal women with basal values <30 ng/mL. We initially enrolled 45 consecutive patients during the period September 2019-September 2020. After an initial visit, patients were instructed to return at 3, 6, 9, 12 and 24 months for measuring serum total 25(OH)D, ionised calcium, creatinine and isoenzyme of alkaline phosphatase (bALP). Here, we report only the per-protocol analysis, because the COVID-19 pandemic precluded adherence to the scheduled visits for some patients. The patients' mean age was 62.4 ± 9.0 years. Mean basal 25(OH)D levels were 20.5 ± 5.3 ng/mL. There was a continuous increase of mean 25(OH)D values ( The long-term administration of calcifediol maintains stable and sustained 25(OH)D concentrations, with no safety concerns.

Sections du résumé

BACKGROUND BACKGROUND
We assessed the long-term (24 months) efficacy and safety of monthly calcifediol (0.266 mg) in the correction and maintenance of total 25(OH)D levels in postmenopausal women with basal values <30 ng/mL.
METHODS METHODS
We initially enrolled 45 consecutive patients during the period September 2019-September 2020. After an initial visit, patients were instructed to return at 3, 6, 9, 12 and 24 months for measuring serum total 25(OH)D, ionised calcium, creatinine and isoenzyme of alkaline phosphatase (bALP). Here, we report only the per-protocol analysis, because the COVID-19 pandemic precluded adherence to the scheduled visits for some patients.
RESULTS RESULTS
The patients' mean age was 62.4 ± 9.0 years. Mean basal 25(OH)D levels were 20.5 ± 5.3 ng/mL. There was a continuous increase of mean 25(OH)D values (
CONCLUSIONS CONCLUSIONS
The long-term administration of calcifediol maintains stable and sustained 25(OH)D concentrations, with no safety concerns.

Identifiants

pubmed: 38892687
pii: nu16111754
doi: 10.3390/nu16111754
pii:
doi:

Substances chimiques

Calcifediol P6YZ13C99Q
Calcium SY7Q814VUP
Vitamin D 1406-16-2
Creatinine AYI8EX34EU
Alkaline Phosphatase EC 3.1.3.1

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Subventions

Organisme : "Sapienza" University
ID : "Progetti di Ricerca - Ateneo 2018"

Auteurs

Marco Occhiuto (M)

Department of Clinical, Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

Jessica Pepe (J)

Department of Clinical, Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

Luciano Colangelo (L)

Department of Clinical, Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

Marco Lucarelli (M)

Department of Experimental Medicine, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

Antonio Angeloni (A)

Department of Experimental Medicine, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

Luciano Nieddu (L)

Department of Humanistic and Social International Sciences, UNINT University, Via Cristoforo Colombo 200, 00147 Rome, Italy.

Viviana De Martino (V)

Department of Clinical, Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

Salvatore Minisola (S)

Department of Clinical, Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

Cristiana Cipriani (C)

Department of Clinical, Internal, Anaesthesiologic and Cardiovascular Sciences, Sapienza University of Rome, Viale del Policlinico 155, 00161 Rome, Italy.

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Classifications MeSH